Actively Recruiting
SYS6010 Combined With Enlonstobart In Recurrent Or Metastatic Head And Neck Squamous Cell Carcinoma
Led by CSPC Megalith Biopharmaceutical Co.,Ltd. · Updated on 2026-01-26
70
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a n open-label, multi-center, phase II study to evaluate the efficacy and safety of SYS6010 combined with Enlonstobart in the recurrent or metastatic head and neck squamous cell carcinoma.
CONDITIONS
Official Title
SYS6010 Combined With Enlonstobart In Recurrent Or Metastatic Head And Neck Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years, male or female
- Histologically confirmed recurrent or metastatic head and neck squamous cell carcinoma unsuitable for radical surgery or concurrent chemoradiotherapy
- For SYS6010 with Enlonstobart group: no prior systemic anti-tumor treatment or disease progression at least 6 months after last neoadjuvant/adjuvant therapy
- For Enlonstobart group: no prior immunotherapy; baseline PD-L1 positivity required if no prior systemic treatment
- At least one measurable lesion by CT or MRI according to RECIST v1.1
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Adequate major organ function within 7 days before first dose
- Negative pregnancy test within 7 days before first dose for women of childbearing potential
- Agreement to use effective contraception from consent until 7 months after last dose; women must not breastfeed, men must avoid sperm donation
- Voluntary participation with ability to understand and sign informed consent
You will not qualify if you...
- Primary tumor sites in nasopharynx, salivary glands, sinuses, skin, or unknown primary origin; combined neuroendocrine carcinoma, mesenchymal tumors, or carcinosarcoma
- Meningeal, brainstem, spinal cord metastasis or compression, or active CNS metastasis, except stable treated supratentorial/cerebellar metastasis without corticosteroid need or on low dose prednisone
- Other cancers within 3 years except certain cured skin, bladder, prostate, or cervical cancers
- Known allergy to SYS6010, Enlonstobart, or humanized monoclonal antibodies
- Unresolved adverse events from prior anti-tumor treatments above Grade 1 (with some exceptions)
- Prior systemic anti-tumor therapy for non-squamous NSCLC except EGFR TKI, unless progression >12 months after adjuvant/neoadjuvant chemotherapy
- Not meeting required washout periods for prior medications or treatments
- Severe cardiovascular or cerebrovascular disease within 6 months
- Tumor invasion of major neck, chest, or abdominal vessels
- History or current interstitial lung disease or pneumonitis, or severe lung function impairment
- Severe infections within 4 weeks or active infections requiring antibiotics within 2 weeks
- Prior long interruption or discontinuation of EGFR-targeted therapy due to toxicity, or current skin diseases needing systemic treatment
- Active autoimmune diseases or history except well-controlled type 1 diabetes or hypothyroidism with hormone replacement
- Pleural or pericardial effusion requiring intervention within 2 weeks
- Active hepatitis B or C infection with specified viral loads
- History of immunodeficiency, including HIV or organ transplant
- Other conditions deemed unsuitable by the investigator such as mental disorders or uncontrolled chronic diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai East Hospital Affiliated To Tongji University
Shanghai, Shanghai Municipality, China, 100176
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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